Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide/formoterol (Symbicort) (Drug); budesonide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Catherine Bonuccelli, Study Director, Affiliation: AstraZeneca
Summary
The purpose of this study is to compare Symbicort with budesonide alone for the treatment of
asthma in children aged 6 to 15 years
Clinical Details
Official title: A 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in evening PEF
Secondary outcome: Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomesRoutine safety assessments described in the protocol
Eligibility
Minimum age: 6 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- At least 6 and maximally 15 years of age
- Diagnosis of asthma and baseline lung function tests as determined by the protocol
- Has required and received treatment with inhaled corticosteroids within the timeframe
and doses specified in the protocol
Exclusion Criteria:
- Severe asthma
- Has required treatment with any non-inhaled corticosteroids within previous 4 weeks,
has sensitivity to drugs specified in the protocol or requires treatment with
beta-blockers
Locations and Contacts
Additional Information
Starting date: April 2003
Ending date: October 2004
Last updated: March 27, 2008
|
